Expandable interbody spacer

ABSTRACT

Embodiments of the present disclosure relate to devices and methods for treating one or more damaged, diseased, or traumatized portions of the spine, including intervertebral discs, to reduce or eliminate associated back pain. In one or more embodiments, the present disclosure relates to an expandable interbody spacer. The expandable interbody spacer may comprise a first jointed arm comprising a plurality of links pivotally coupled end to end. The expandable interbody spacer further may comprise a second jointed arm comprising a plurality of links pivotally coupled end to end. The first jointed arm and the second jointed arm may be interconnected at a proximal end of the expandable interbody spacer. The first jointed arm and the second jointed arm may be interconnected at a distal end of the expandable interbody spacer.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. patentapplication Ser. No. 13/837,209, filed Mar. 15, 2013, which is acontinuation-in-part of U.S. patent application Ser. No. 13/483,852,filed May 20, 2012, now issued as U.S. Pat. No. 9,044,342, which arehereby incorporated by reference in their entirety.

FIELD OF THE INVENTION

The present disclosure relates to embodiments of devices and methods fortreating one or more damaged, diseased, or traumatized portions of thespine, including intervertebral discs, to reduce or eliminate associatedback pain. In one or more embodiments, the present disclosure relates toan expandable interbody spacer. In addition, the present disclosuredescribes tools and methods for implanting the disclosed devices.

BACKGROUND OF THE INVENTION

The vertebrate spine is the axis of the skeleton providing structuralsupport for the other body parts. In humans, the normal spine has sevencervical, twelve thoracic and five lumbar segments. The lumbar spinesits upon the sacrum, which then attaches to the pelvis, and in turn issupported by the hip and leg bones. The bony vertebral bodies of thespine are separated by intervertebral discs, which act as joints butallow known degrees of flexion, extension, lateral bending, and axialrotation.

The typical vertebra has a thick anterior bone mass called the vertebralbody, with a neural (vertebral) arch that arises from the posteriorsurface of the vertebral body. The centra of adjacent vertebrae aresupported by intervertebral discs. Each neural arch combines with theposterior surface of the vertebral body and encloses a vertebralforamen. The vertebral foramina of adjacent vertebrae are aligned toform a vertebral canal, through which the spinal sac, cord and nerverootlets pass. The portion of the neural arch which extends posteriorlyand acts to protect the spinal cord's posterior side is known as thelamina. Projecting from the posterior region of the neural arch is thespinous process.

The intervertebral disc primarily serves as a mechanical cushionpermitting controlled motion between vertebral segments of the axialskeleton. The normal disc is a unique, mixed structure, comprised ofthree component tissues: the nucleus pulpous (“nucleus”), the annulusfibrosus (“annulus”) and two vertebral end plates. The two vertebral endplates are composed of thin cartilage overlying a thin layer of hard,cortical bone which attaches to the spongy, richly vascular, cancellousbone of the vertebral body. The end plates thus act to attach adjacentvertebrae to the disc.

The spinal disc and/or vertebral bodies may be displaced or damaged dueto trauma, disease, degenerative defects, or wear over an extendedperiod of time. One result of this displacement or damage to a spinaldisc or vertebral body may be chronic back pain. A common procedure fortreating damage or disease of the spinal disc or vertebral body mayinvolve partial or complete removal of an intervertebral disc. Animplant, which may be referred to as an interbody spacer, can beinserted into the cavity created where the intervertebral disc wasremoved to help maintain height of the spine and/or restore stability tothe spine. An example of an interbody spacer that has been commonly usedis a cage, which typically is packed with bone and/orbone-growth-inducing materials. However, there are drawbacks associatedwith conventional interbody spacers, such as cages and other designs.For instances, conventional interbody spacers may be too large and bulkyfor introduction into the disc space in a minimally invasive manner,such as may be utilized in a posterior approach. Further, theseconventional interbody spacers may have inadequate surface area contactwith the adjacent endplates if sized for introduction into the discspace in a minimally invasive manner. In addition, conventionalinterbody spacers designed for introduction into the disc space in aminimally invasive manner may lack sufficient space for packing ofbone-growth-inducing material, thus potentially not promoting thedesired graft between the adjacent endplates.

Therefore, a need exists for an interbody spacer that can be introducedin a minimally manner that provides a desired amount of surface areacontact with the adjacent endplates and has an increased space forpacking of bone-growth-inducing material.

SUMMARY OF THE INVENTION

Embodiments of the present disclosure relates to an expandable interbodyspacer. The expandable interbody spacer may comprise a first jointed armcomprising a plurality of links pivotally coupled end to end. Theexpandable interbody spacer further may comprise a second jointed armcomprising a plurality of links pivotally coupled end to end. The firstjointed arm and the second jointed arm may be interconnected at aproximal end of the expandable interbody spacer. The first jointed armand the second jointed arm may be interconnected at a distal end of theexpandable interbody spacer. The first jointed arm and the secondjointed arm may each be configured to fold inward in opposite directionsto place the expandable interbody spacer in an expanded position.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present disclosure will be more readily understoodwith reference to the embodiments thereof illustrated in the attacheddrawing figures, in which:

FIG. 1 is a top view of an expandable interbody spacer shown in acollapsed position in accordance with embodiments of the presentdisclosure;

FIG. 2 is a side view of the expandable interbody spacer of FIG. 1 shownin a collapsed position;

FIG. 3 is a proximal end view of the expandable interbody spacer of FIG.1 shown in a collapsed position;

FIG. 4 is a distal end view of the expandable interbody spacer of FIG. 1shown in a collapsed position;

FIG. 5 is an exploded view of the expandable interbody spacer of FIG. 1;

FIG. 6 is a top view of the expandable interbody spacer of FIG. 1 shownin an expanded position;

FIG. 7 is a right side view of the expandable interbody spacer of FIG. 1shown in an expanded position;

FIG. 8 is a left side view of the expandable interbody spacer of FIG. 1shown in an expanded position;

FIG. 9 is a proximal end view of the expandable interbody spacer of FIG.1 shown in an expanded position;

FIG. 10 is a distal end view of the expandable interbody spacer of FIG.1 shown in an expanded position;

FIG. 11 is a view showing disc space between adjacent vertebrae inaccordance with embodiments of the present disclosure;

FIG. 12 is a view of a tool for insertion of an expandable interbodyspacer in accordance with embodiments of the present disclosure;

FIG. 13 is a view showing the tool of FIG. 12 introducing an expandableinterbody spacer into a disc space in a collapsed position in accordancewith embodiments of the present disclosure;

FIG. 14 is a view showing the tool of FIG. 12 expanding an expandableinterbody spacer in a disc space in accordance with embodiments of thepresent disclosure;

FIG. 15 is a view showing a funnel for introduction ofbone-growth-inducing material into a disc space in accordance withembodiments of the present disclosure;

FIG. 16 is an exploded view of another embodiment of an expandableinterbody spacer;

FIG. 17 is a top view of another embodiment of an expandable interbodyspacer shown in a collapsed position;

FIG. 18 is a top view of the expandable interbody spacer of FIG. 17shown in an expanded position;

FIG. 19 is an exploded view of the expandable interbody spacer of FIG.17;

FIG. 20 is an exploded view of a link of a jointed arm of the expandableinterbody spacer of FIG. 17;

FIG. 21 is a top view of another embodiment of an expandable interbodyspacer shown in a collapsed position;

FIG. 22 is a top view of the expandable interbody spacer of FIG. 21shown in an expanded position;

FIG. 23 is a view of the expandable interbody spacer of FIG. 21 shown ina disc space in a collapsed position;

FIG. 24 is a view of the expandable interbody spacer of FIG. 21 shown ina disc space in an expanded position;

FIG. 25 is a top view of a tool shown engaging the expandable interbodyspacer of FIG. 21 in accordance with embodiments of the presentdisclosure;

FIG. 26 is a view showing the tool of FIG. 24 expanding the expandableinterbody spacer of FIG. 24 in a disc space in accordance withembodiments of the present disclosure;

FIG. 27A is an isometric view of an exemplary expandable interbodyspacer in an expanded position, in accordance with a further embodimentof the disclosure;

FIG. 27B is an isometric view of the expandable interbody spacer of FIG.27A in the collapsed position;

FIG. 28 is an exploded view of the expandable interbody spacer of FIG.27A.

FIG. 29 depicts a cross-sectional view of the expandable interbodyspacer of FIG. 27A in the collapsed position;

FIG. 30 depicts an embodiment of an exemplary tool for implanting anembodiment of an exemplary expandable interbody spacer, in accordancewith the principles of the present disclosure;

FIG. 31 depicts a partially-exploded view of various components of thetool shown in FIG. 30;

FIG. 32A depicts a cross-sectional view of a proximal portion of thetool of FIG. 30;

FIG. 32B depicts a cross-sectional view of an actuator assembly;

FIG. 32C depicts an exploded view of the actuator assembly;

FIGS. 33-43 depict various views of components of the exemplary tool ofFIG. 30 and their interaction with an exemplary interbody spacer; and

FIG. 44 depicts a final implanted configuration of an exemplaryembodiment of an expandable interbody spacer.

Throughout the drawing figures, it should be understood that likenumerals refer to like features and structures.

DETAILED DESCRIPTION OF THE INVENTION

The preferred embodiments of the disclosure will now be described withreference to the attached drawing figures. The following detaileddescription of the invention is not intended to be illustrative of allembodiments. In describing preferred embodiments of the presentdisclosure, specific terminology is employed for the sake of clarity.However, the embodiments described herein are not intended to be limitedto the specific terminology so selected. It is to be understood thateach specific element includes all technical equivalents that operate ina similar manner to accomplish a similar purpose.

As used herein, the term “proximal” may refer to a portion of a deviceor component thereof disposed closest to an operator or healthcareprofessional during an implantation procedure. Conversely, the term“distal” may refer to a portion of a device or component thereofdisposed opposite the proximal portion and disposed farther from theoperator or healthcare professional during an implantation procedure. Asdiscussed below, the embodiments of expandable interbody spacersdescribed herein may be implanted via any suitable approach known in theart. It is contemplated, however, that the disclosed embodiments may beimplanted via an offset (e.g., 20-40 degree offset) posterior approach.Accordingly, solely for orientation purposes, a “proximal” portion ofthe device, when implanted, may be disposed posteriorly relative to apatient, if implanted via a posterior approach.

Referring to FIGS. 1-10, an expandable interbody spacer 10 is shown inaccordance with embodiments of the present disclosure. In theillustrated embodiment, the expandable interbody spacer 10 has aproximal end 20 and a distal end 30. The expandable interbody spacer 10may include a first jointed arm 40 and a second jointed arm 50positioned on either side of longitudinal axis 15 of the spacer 10. Thefirst and second jointed arms 40, 50 may be interconnected at theproximal end 20, for example, by a proximal connection member 60. Thefirst and second jointed arms 40, 50 may be interconnected at the distalend 30, for example, by a distal connection member 70. The first andsecond jointed arms 40, 50 of the expandable interbody spacer 10 may bemade from a number of materials, including titanium, stainless steel,titanium alloys, non-titanium alloys, polymeric materials, plasticcomposites, polyether ether ketone (“PEEK”) plastic material, ceramic,elastic materials, and combinations thereof. While the expandableinterbody spacer 10 may be used with a posterior, anterior, lateral, orcombined approach to the surgical site, the spacer 10 may beparticularly suited with a posterior approach.

The first jointed arm 40 has a proximal end 80 and a distal end 90. Theproximal end 80 may be pivotally coupled to the proximal connectionmember 60. The distal end 90 may be pivotally coupled to the distalconnection member 70. Any of a variety of different fasteners may beused to pivotally couple the proximal end 80 and the distal end 90 andthe proximal connection member 60 and the distal connection member 70,such as pins 100, for example. In another embodiment (not illustrated),the connection may be a hinged connection. As illustrated, the firstjointed arm 40 may comprise a plurality of links that are pivotallycoupled to one another. In the illustrated embodiment, the first jointedarm 40 comprises first link 110, second link 120, and third link 130.When the spacer 10 is in a collapsed position, the first link 110,second link 120, and third link may be generally axially aligned. Asillustrated, the first link 110, second link 120, and third link 130 maybe connected end to end. When the spacer 10 is in a collapsed position,the first link 110, second link 120, and third link 130 may be generallyaxially aligned. The first link 110 and the second link 120 may bepivotally coupled, and the second link 120 and the third link 130 mayalso be rotatably coupled. Any of a variety of different fasteners maybe used to pivotally couple the links 110, 120, 130, such as pins 100,for example. In another embodiment (not illustrated), the coupling maybe via a hinged connection.

As best seen in FIGS. 1, 5-7, 9, and 10, an upper surface 140 of thefirst jointed arm 40 may be defined by the links 110, 120, 130. Theupper surface 140 should allow for engagement of the first jointed arm40 with one of the adjacent vertebral bodies. In some embodiments, theupper surface 140 may include texturing 150 to aid in gripping theadjacent vertebral bodies. Although not limited to the following, thetexturing 150 can include teeth, ridges, friction-increasing elements,keels, or gripping or purchasing projections.

As best seen in FIGS. 7, 9, and 10 a lower surface 160 of the firstjointed arm 40 may be defined by the links 110, 120, 130. The lowersurface 160 should allow for engagement of the first jointed arm 40 withone of the adjacent vertebral bodies. In some embodiments, the lowersurface 160 may include texturing 170 to aid in gripping the adjacentvertebral bodies. Although not limited to the following, the texturing170 can include teeth, ridges, friction-increasing elements, keels, orgripping or purchasing projections.

The second jointed arm 50 has a proximal end 180 and a distal end 190.The proximal end 180 may be pivotally coupled to the distal connectionmember 70. The distal end 190 may be pivotally coupled to the distalconnection member 70. Any of a variety of different fasteners may beused to pivotally couple the proximal end 180 and the distal end 190 andthe proximal connection member 60 and the distal connection member 70,such as pins 100, for example. In another embodiment (not illustrated),the connection may be a hinged connection. As illustrated, the secondjointed arm 50 may comprise a plurality of links that are pivotallycoupled to one another. In the illustrated embodiment, the secondjointed arm 50 comprises first link 200, second link 210, and third link220. When the spacer 10 is in a collapsed position, the first link 200,second link 210, and third link 220 may be generally axially aligned. Asillustrated, the first link 200, second link 210, and third link 220 maybe connected end to end. The first link 200 and the second link 210 maybe pivotally coupled, and the second link 210 and the third link 220 mayalso be pivotally coupled. Any of a variety of different fasteners maybe used to pivotally couple the links 200, 210, 220, such as pins 100,for example. In another embodiment (not illustrated), the coupling maybe via a hinged connection.

As best seen in FIGS. 1, 2, 6, and 8-10, an upper surface 230 of thesecond jointed arm 50 may be defined by the links 200, 210, 220. Theupper surface 230 should allow for engagement of the second jointed arm50 with one of the adjacent vertebral bodies. In some embodiments, theupper surface 230 may include texturing 240 to aid in gripping theadjacent vertebral bodies. Although not limited to the following, thetexturing 240 can include teeth, ridges, friction-increasing elements,keels, or gripping or purchasing projections.

As best seen in FIGS. 8-10, a lower surface 250 of the second jointedarm 50 may be defined by the links 200, 210, and 220. The lower surface250 should allow for engagement of the second jointed arm 50 with one ofthe adjacent vertebral bodies. In some embodiments, the lower surface250 may include texturing 260 to aid in gripping the adjacent vertebralbodies. Although not limited to the following, the texturing 260 caninclude teeth, ridges, friction-increasing elements, keels, or grippingor purchasing projections.

With reference now to FIGS. 3, 5, and 9, a bore 270 extends throughproximal connection end 60. The bore 270 may extend generally parallelto the longitudinal axis 12 (see FIG. 1) of the spacer 10. The firstjointed arm 40 and the second jointed arm 50 may define a hollowinterior portion (not shown) that extends axially through the spacer 10.The bore 270 in the proximal connection end 60 may communicate with thishollow interior portion. As best shown on FIG. 5, the distal connectionend 70 may include an opening 280. As illustrated, the opening 280 mayface inward and may not extend all the way through the distal connection70. In one embodiment, the opening 280 may be generally aligned with thebore 270 in the proximal connection end 60 such at a tool (e.g., tool340 shown on FIG. 12) inserted into the bore 270 may be received in theopening 280 for placement of the spacer 10 into a disc space and/orexpansion of the spacer 10.

FIGS. 1-4 illustrate the expandable interbody spacer 10 in a collapsedposition. In accordance with present embodiments, the expandableinterbody spacer 10 may be laterally expanded to an expanded position.FIGS. 6-10 illustrate the expandable interbody spacer 10 in an expandedposition. In the expanded position, the first arm 40 and the second arm50 have each been folded inward in opposite directions. For example, theproximal end 80 and the distal end 90 of the first arm 40 may be foldedcloser together. The links 110, 120, 130 should pivot with respect toone another when the first arm 40 is folded inward. The proximal end 80should pivot at the proximal connection end 60, and the distal end 90should pivot at the distal connection end 70. By way of further example,the proximal end 180 and the distal end 190 of the second arm 50 mayalso be folded together. The links 200, 210, 220 should pivot withrespect to another when the second arm is folded inward. The proximalend 180 should pivot at proximal connection end 60, and the distal end190 should pivot at the distal connection end 70. After placement in theexpanded position, the expandable interbody spacer 10 can be secured inthe expanded position to prevent collapse of the expandable interbodyspacer 10 upon application of spacer. Any of a variety of differenttechniques may be used to secure the expandable interbody spacer 10,including pins or other suitable locking mechanism, for example.

As illustrated by FIG. 6, the first and second jointed arms 40, 50define an interior cavity 290 when in an expanded position. The interiorcavity 290 may be filled with a bone-growth-inducing material, such asbone material, bone-growth factors, or bone morphogenic proteins. Aswill be appreciated by those of ordinary skill in the art, thebone-growth-inducing material should induce the growth of bone material,thus promoting fusion of the adjacent vertebra.

The expandable interbody spacer 10 may be sized to accommodate differentapplications, different procedures, implantation into different regionsof the spine, or size of disc space. For example, the expandableinterbody spacer 10 may have a width W1 (as shown on FIG. 1) prior toexpansion of about 8 mm to about 22 mm and alternatively from about 10mm to about 13 mm. By way of further example, the expandable interbodyspacer 10 may be expanded to a width W2 (as shown on FIG. 6) in a rangeof about 26 mm to about 42 mm and alternatively from about 16 mm toabout 32 mm. It should be understood that the width W1 or W2 whetherprior to, or after, expansion generally refers to the width of theexpandable interbody spacer 10 extending transverse to the longitudinalaxis 12 of the spacer 10. In general, the width W2 of the expandableinterbody spacer 10 after expansion should be greater than the width W1of the expandable interbody spacer 10 prior to expansion.

In accordance with present embodiments, the expandable interbody spacer10 may be used in the treatment of damage or disease of the vertebralcolumn. In one embodiment, the expandable interbody spacer 10 may beinserted into a disc space between adjacent vertebrae in which theintervertebral disc has been partially or completely removed. FIG. 11illustrates a spinal segment 300 into which the expandable interbodyspacer 10 (e.g., FIGS. 1-10) may be inserted. The spinal segment 300includes adjacent vertebrae, identified by reference numbers 310 and320. Each of the adjacent vertebrae 310, 320 has a correspondingendplate 315, 325. The disc space 330 is the space between the adjacentvertebrae 310, 320. FIG. 12 illustrates a tool 340 that may be used inthe insertion of the expandable interbody spacer 10 into the disc space330. The tool 340 includes a shaft 350 having an elongated end portion360 for coupling to the expandable interbody spacer 10. The elongatedend portion 360 has a distal tip 370.

FIGS. 13 and 14 illustrate introduction of an expandable interbodyspacer 10 into the disc space 330 using tool 340. For illustrativepurposes, the upper vertebra 330 shown on FIG. 11 has been removed fromFIGS. 13 and 14. As illustrated, the spacer 10 may be secured to thetool 340. For example, the elongated end portion 360 of the tool 340 maybe disposed through the bore 270 (e.g., see FIG. 5) in the proximalconnection end 60 with the distal tip 370 (e.g., see FIG. 12) of the endportion 360 secured in the opening 280 (e.g., see FIG. 5) in the distalconnection end 70. As illustrated by FIG. 13, the tool 340 may introducethe spacer 10 into the disc space 330 through an access cannula 380.After introduction into the disc space 330, the spacer 10 may belaterally expanded. In accordance with present embodiments, the spacer10 can be laterally expanded by folding the first arm 40 and the secondarm 50 inward. By expanding laterally, the spacer 10 has an increasedsurface area contact with the endplate 325. In addition, the spacer 10may engage harder bone around the apophyseal ring. As previouslymentioned, an interior cavity 290 should be formed in the spacer 10 whenin the expanded position. The tool 340 may then be detached from thespacer 10 and removed from the cannula 380. As illustrated by FIG. 15, afunnel 390 may then be placed on the cannula 380. Bone-growth inducingmaterial may then be placed into the interior cavity 290 through thecannula 380. Because the spacer 10 has been laterally expanded, theinterior cavity 290 should have a desirable amount of space for packingof the bone-growth-inducing material.

FIG. 16 illustrates an expandable interbody spacer 10 in accordance withan alternative embodiment. In the illustrated embodiment, the expandableinterbody spacer 10 comprises a first jointed arm 40 and a secondjointed arm 50. The first jointed arm 40 has a proximal end 80 and adistal end 90. The first jointed arm 40 comprises a plurality of links110, 120, 130 connected end to end, for example, by pins 100. The firstjointed arm 40 further may comprise washers 105 (e.g, PEEK washers) thatmay be disposed between the links 110, 120, 130 at their connections.The second jointed arm 50 has a proximal end 180 and a distal end 190.The second jointed arm 50 comprises a plurality of links 200, 210, 220connected end to end, for example, by pins 100. The second jointed arm50 further may comprise washers 105 (e.g, PEEK washers) that may bedisposed between the links 200, 210, 220 at their connections. Washers105 may also be disposed between the first arm 40 and the proximalconnection member 60 and the distal connection member 70 at theirrespective connections. Washers 105 may also be disposed between thesecond arm 50 and the proximal connection member 60 and the distalconnection member 70 at their respective connections. The washers 105should have an interference fit to cause friction such that the spacer10 may hold its shape in the entire range of the expanded implant.

The proximal ends 80, 180 may be pivotally coupled, for example, by pin100, as shown on FIG. 19. The distal ends 90, 180 may also be pivotallycoupled, for example, by pin 100, as shown on FIG. 19. The first jointedarm 40 comprises first link 110 and third link 130, the first link 110and the third link 130 being pivotally coupled. In contrast to the firstjointed arm 40 of FIGS. 1-10, there

Referring now to FIGS. 17-19, an expandable interbody spacer 10 isillustrated in accordance with another embodiment of the presentdisclosure. In the illustrated embodiment, the expandable interbodyspacer 10 comprises a first jointed arm 40 and a second jointed arm 50.The first jointed arm 40 has a proximal end 80 and a distal end 90. Thesecond jointed arm 50 has a proximal end 180 and a distal end 190. Theproximal ends 80, 180 may be pivotally coupled, for example, by pin 100,as shown on FIG. 19. The distal ends 90, 180 may also be pivotallycoupled, for example, by pin 100, as shown on FIG. 19. The first jointedarm 40 comprises first link 110 and third link 130, the first link 110and the third link 130 being pivotally coupled. In contrast to the firstjointed arm 40 of FIGS. 1-10, there is no second link 120. As shown byFIG. 20, the third link 130 may comprise a first link segment 400 and asecond link segment 410, which may be secured to one another by pins420, for example. First link segment 400 and second link segment 410 mayalso have a tongue-and-groove connection, for example a groove 430 inthe first link segment 400 may receive a tongue 440 of the second linksegment 410. The second jointed arm comprises first link 200 and thirdlink 220, the first link 200 and the third link 220 being pivotallycoupled. In contrast to the second joint arm 50 of FIGS. 1-10, there isno second link 210.

In accordance with present embodiments, lateral expansion of theexpandable interbody spacer 10 of FIGS. 17-19 may include folding thefirst arm 40 and the second arm 50 inward. For example, the proximal end80 and the distal end 90 of the first arm 40 may be folded together, andthe proximal end 180 and the distal end 190 of the second arm 50 mayalso be folded together.

Referring now to FIGS. 21 and 22, an expandable interbody spacer 10 isillustrated in accordance with another embodiment of the presentdisclosure. In the illustrated embodiment, the expandable interbodyspacer 10 has a proximal end 20 and a distal end 30. The expandableinterbody spacer 10 may include a first jointed arm 40 and a secondjointed arm 50 positioned on either side of longitudinal axis 12 of thespacer 10. As illustrated, the expandable interbody spacer 10 furthermay comprise an internal screw 450. The internal screw 450 may comprisea head 460 and an elongated body 470, which may extend generallyparallel to the longitudinal axis 12 of the spacer 10. In someembodiments, the internal screw 450 may extend from the proximal end 20to the distal end 30 of the spacer 10. In one embodiment, the elongatedbody 470 may be retractable. For example, the elongated body 470 mayretract into the head 460, as shown on FIG. 22.

As illustrated by FIGS. 23 and 24, the spacer 10 may be introduced intothe disc space 330, wherein the spacer 10 can be laterally expanded. Inaccordance with present embodiments, the spacer 10 can be laterallyexpanded by folding the first arm 40 and the second arm 50 inward. Insome embodiments, the elongated body 470 may be retracted into the head460 to cause folding of the first arm 40 and the second arm 50 inward,as the first arm 40 and the second arm 50 are secured to the distal end480 of the internal screw 450.

FIG. 25 shows attachment of a tool 490 to the expandable interbodyspacer 10 of FIGS. 22 and 23 in accordance with embodiments of thepresent disclosure. As illustrated, the tool 490 may have an attachmentend 500, which can be secured to the head 460 of the internal screw 450.As shown by FIG. 26, the tool 40 can be used to introduce the spacer 10into the disc space 330, wherein the spacer 10 can be laterallyexpanded.

Turning now to FIG. 27A-29, there are depicted multiple views of afurther embodiment of an expandable interbody spacer 2700, in accordancewith an aspect of the present disclosure. The expandable interbodyspacer 2700 may include one or more features of any of the otherinterbody spacers discussed herein. For example, although the spacer2700 and its components may be made of titanium, any suitablebiocompatible material known in the art may be used.

With reference to FIG. 27A, for example, spacer 2700 may include, amongother things, a proximal portion 2702. Proximal portion 2702 may includea substantially cylindrical portion 2703. Cylindrical portion 2703 mayinclude a complete cylindrical shape or a partial cylindrical shape. Inaddition, cylindrical portion 2703 may define a lumen 2704 therethrough.A surface of the lumen 2704 may include one or more geometric features,such as, for example, screw threads 2705, as described in greater detailbelow. In one embodiment, lateral surfaces of cylindrical portion 2703may include one or more geometric features 2706 to facilitate engagementby a tool 3000, as discussed below in greater detail. The geometricfeatures 2706 may include any suitable shape and/or configuration. Inone embodiment, the geometric features 2706 may include elongate notchesdisposed in the side walls that define cylindrical portion 2703.Further, the elongate notches may extend into the side walls in adirection that is substantially perpendicular.

A plurality of cantilevered ledges 2707 may extend distally from adistal portion of cylindrical portion 2703. Aside from being disposed inan opposing relation to one another, the cantilevered ledges 2707 may besubstantially similar to one another. The ledges 2707 may include anysuitable configuration, shape, and/or size known in the art. In oneembodiment, the ledges 2707 may define a space 2708 therebetween forreceiving a plurality of links (as described below) of spacer 2700.External surfaces (e.g., inferior and superior surfaces) of ledges 2707may include texturing 150 to aid in gripping adjacent vertebral bodies,as described herein. The external surfaces may also be configured topromote bone ingrowth. For example, in one embodiment, the externalsurfaces of ledges 2707 may include a porous configuration or mayinclude a coating of, e.g., hydroxyapatite. External edges of ledges2707 may include any suitable configuration for matingly coupling withcorresponding portions of the plurality of links discussed below. In oneembodiment, the external edges of ledges 2707 may be curved tofacilitate the plurality of links pivoting relative to each of ledges2707. Further, each of ledges 2707 may include one or more openings 2707a for receiving a pivot pin 2709 therethrough, as described below ingreater detail.

With continued reference to FIGS. 27A-29, proximal portion 2702 may berotatably coupled via a plurality of pivot pins 2709 to links 2710 and2712. Links 2710 and 2712 may be substantially similar to one another.Indeed, as depicted in, e.g., FIG. 27A, links 2710 and 2712 may bepositioned as mirror images of each other. Thus, for the purposes ofbrevity, similar portions of links 2710 and 2712 will be describedtogether. Proximal portions 2714 of links 2710 and 2712 may be receivedin space 2708. The proximal portions 2714 of links 2710, 2712 may beappropriately configured and dimensioned to fit between ledges 2707. Inaddition, each of proximal portions 2714 includes a through-hole 2716for receiving a pivot pin 2709. The through-hole 2716 may be disposed ina scalloped cut-out on proximal portions 2714 of each of links 2710,2712.

Pivot pin 2709 may include any suitable fastener known in the art formovably coupling links 2710 and 2712 to proximal portion 2702. In oneembodiment, pivot pin 2709 may be inserted and retained within openings2707 a and through-holes 2716 via an interference or friction fit.

In some embodiments, an interface between one or both of links 2710 and2712 and proximal portion 2702 may be configured to retain one or bothof links 2710 and 2712 in a predetermined position relative to proximalportion 2702. For example, an edge of ledge 2707 may interact with awall 2717 to frictionally retain in a predetermined position relative toproximal portion 2702. In one embodiment, the wall 2717 may include araised portion (not shown), such as, e.g., a rounded bump, or othersuitable feature against which the edge of ledge 2707 may engage.

Superior and inferior surfaces of links 2710 and 2712 may also includesuitable texturing 150 as described above. In addition, the superior andinferior surfaces may be configured to promote bone ingrowth, asdescribed above. Each link 2710 and 2712 also may define one moreopenings 2718 therethrough. The openings 2718 may include any suitableconfiguration known in the art. In one embodiment, openings 2718 mayinclude a substantially rectangular configuration. In other embodiments,openings 2718 may include other shapes. In one embodiment, the openings2718 may be disposed distally of wall 2717. Openings 2718 may beconfigured as bone graft windows, allowing facilitating bone ingrowthinto an interior of spacer 2700 through openings 2718 An edge of opening2718 may be appropriately beveled, chamfered, and/or rounded, as isknown in the art. Further, opening 2718 may be generally disposed in acentral portion of each of links 2710 and 2712.

A distal end portion of links 2710, 2712 may be configured to be movablycoupled to another link, as discussed herein. In one embodiment, thedistal end portions of links 2710, 2712 may define a male hinge 2719that includes a hole 2720 therethrough. The hole 2720 may be configuredto receive a pivot pin 2709 for rotatable coupling the links 2710, 2712to adjacent links described below. In one embodiment, a wallperpendicular to hinge 2719 may define one or more position retainingfeatures 2721. As will be described below, the position retainingfeatures 2721 may be configured to interact with corresponding featureson an adjacent link to frictionally retain links in a predeterminedposition.

The ends of each of links 2710, 2712 that are opposite to the endscoupled to proximal portion 2702 may be movably coupled to links 2722and 2724. Each of links 2722 and 2724 may be substantially similar toone another. Thus, those of ordinary skill in the art will understandthat either link 2722 or link 2724 may include features of the otherlink 2722 or link 2724. A proximal end portion of each of links 2722 and2724 may define a recess 2725 for receiving hinge 2719. The recess 2725may be disposed between a pair of proximally extending arms 2725 a and2725 b. Each of arms 2725 a, 2725 b may be substantially similar to oneanother and, thus, for the purposes of efficiency, only one arm 2725 awill be discussed.

Arm 2725 a may include any suitable shape and/configuration known in theart. In one embodiment, an external surface of arm 2725 a may be roundedto facilitate rotating relative to link 2712 or 2710. A lateral surfaceof arm 2725 a may include one or more position retaining features 2727for engaging position retaining features 2721. In use, as links 2724 and2712 may rotate relative to one another, for example, position retainingfeatures 2721 and 2727 may frictionally engage one another to retainlinks 2724 and 2712 in a desired position. Position retaining features2727 may be similar to position retaining features 2721. For example, inone embodiment, position retaining feature 2727 may be a bump that israised relative to a remaining surface of arm 2725 a.

Each link 2722 and 2724 may also include one or more openings 2718disposed generally in a central portion of links 2722 and 2724. Asdiscussed above, openings 2718 may be configured to extend through eachrespective link 2722, 2724, and may be configured to facilitatebone-ingrowth. One or more edges of openings 2718 may be beveled,rounded, and/or chamfered as known in the art.

A distal end of each link 2722 and 2724 may include a plurality ofextensions 2729, 2730. Extensions 2729, 2730 may be configured to extendaway from a central portion of the links 2722, 2724, and may beconfigured to define a space 2732 therebetween. The space 2732 may beconfigured to receive a distal component of spacer 2700. Each ofextensions 2729, 2730 may include a through-hole 2734 therein. Thethrough-hole 2734 may include any suitable configuration known in theart. The through-hole 2734 may be configured to receive a respectivepivot pin 2709 for movably coupling links 2722, 2724 to the distalcomponent discussed in greater detail below.

Inward facing surfaces of one or both of extensions 2729, 2730 may beconfigured to interact or engage with corresponding surfaces of theextensions 2729, 2730 of an opposing link. For example, as shown in FIG.28, the inward facing surfaces of extensions 2729, 2730 of one of links2722, 2724 may include a plurality of teeth, recesses, protrusions,notches, or the like, that may be configured to engage correspondinggeometry disposed on the inward facing surfaces of the extensionsdisposed on the other of links 2722, 2724. In the preferred embodiment,the inward facing surfaces of extensions 2729, 2730 may include aplurality of gear teeth 2736. The gear teeth 2736 of each extension2729, 2730 may engage gear teeth 2736 of the opposing link to facilitaterotating one link relative to the other in a single plane.

Each of links 2722 and 2724 may be movably coupled to a distal component2740. Distal component 2740 may include a substantially trapezoidalconfiguration. That is, distal component 2740 may taper in the distaldirection from a larger width dimension to a smaller width dimension.With reference to FIG. 28, a proximal face of distal component 2740 mayinclude an opening 2742 in communication with a hole 2744 through distalcomponent 2740. As shown in, e.g., FIG. 27A, hole 2744 extendscompletely through distal component 2740. Hole 2744 may include anysuitable configuration known in the art. In one embodiment, hole 2744may include a substantially conical configuration as it tapers towards asmaller diameter in its distal portion. As will be discussed below, hole2744 may include internal threads for engaging with an implantationtool.

Superior and inferior surfaces of distal component 2740 may beconfigured to receive extensions 2729, 2730. Accordingly, as best shownin FIG. 28, for example, these surfaces may include a stepped portion2746 for receiving extensions 2729, 2730 of each link 2722, 2724.Stepped portion 2746 may include a plurality of openings 2748 forreceiving a pivot pin 2709 therein to rotatably couple the links 2722,2724 to distal component 2740. Those of ordinary skill in the art willunderstand that links 2722, 2724 may be coupled to distal component 2740by any suitable means known in the art. Distal component 2740 mayinclude a raised portion disposed distally of stepped portion 2746. Theraised portion 2750 may include any suitable configuration known in theart. In one embodiment, the raised portion 2750 may include a distallytapering configuration, as shown in FIG. 27A. As also shown in FIG. 27A,distal component 2740 may include a curved external configuration.

With reference now to FIGS. 28-29, the spacer 2700 may be maintained inan expanded configuration (shown in FIG. 27A) by any suitable mechanismknown in the art. As discussed above, the spacer 2700 may includecertain position retaining features. To more permanently retain anexpanded configuration of spacer 2700, the spacer 2700 may include alocking feature 2760. Those of ordinary skill in the art will understandthat locking feature 2760 may include any suitable configuration knownin the art. In one embodiment, locking feature 2760 may include asubstantially cylindrical configuration. In addition, locking feature2760 may define a lumen 2762 therethrough. In one embodiment, the wallsof the lumen 2762 may include a plurality of geometric configurations2762 a to allow a tool (described in greater detail below) to engage androtate locking feature 2760. Further, locking feature 2760 may beconfigured and dimensioned to be received within lumen 2704 of proximalportion 2702, as shown in FIG. 29. In one embodiment, an externalsurface of locking feature 2760 may include suitable geometric featuresfor engaging lumen 2704. In the embodiment where lumen 2704 includesthreads 2705, the external surface of locking feature 2760 may includecorresponding threads 2764. The threads 2705 in lumen 2704 and threads2764 may cooperate to only allow locking feature 2760 to be advancedinto lumen 2704 without being withdrawn, regardless of whether lockingfeature is rotated clockwise or counter-clockwise. For example, in oneembodiment, threads 2705 may terminate short of the opening to lumen2704. In addition, or alternatively, one or more raised circumferentialor partially circumferential protrusions 2705 a may be formed justinside of the opening to lumen 2704. In such embodiments, lockingfeature 2760 may be pre-disposed within lumen 2704 during amanufacturing or assembly process and before delivery to a user orhealthcare professional. Thus, the user or healthcare professional isonly able to rotate locking feature 2762 to advance it further intolumen 2704 and is unable to remove locking feature 2762 from 2704.

With reference to FIG. 29, and as will be discussed in greater detailbelow, locking feature 2760 may be configured to be advanced into lumen2704 and protrude out of cylindrical portion 2703 into space 2708,which, as shown in FIG. 29, is occupied by proximal portions 2714 oflinks 2710 and 2712 when the spacer 2700 is in the collapsedconfiguration. When the spacer 2700 is in the expanded position, theproximal portions 2714 may be moved out of the space 2708. Accordingly,locking feature 2760 may be rotated and consequently advanced furtherinto lumen 2704 so that a distal portion of locking feature 2760 extendsout of lumen 2708 and into the space 2704. In this position, the lockingfeature 2762 may be configured to prevent links 2710 and 2712 fromreturning to their collapsed positions.

The components of spacer 2700 may be fabricated from any suitablematerial known in the art, including, but not limited to those describedabove. In one embodiment, one or more components of spacer 2700 may befabricated from titanium. Further, portions of spacer 2700 may includeany suitable coating known in the art, including, but not limited to,coatings of suitable therapeutic, antiseptic, anesthetic, and/orantibiotic. In addition, as alluded to above, portions of spacer 2700may be configured to promote bone ingrowth into the structure of spacer2700.

Turning now to FIGS. 30-31, there is depicted an exemplary embodiment ofa tool 3000 for effecting implantation, removal, and otherwisemanipulation of the various embodiments of expandable interbody spacersdescribed herein. Tool 3000 may include a plurality of components, eachof which will be discussed in greater detail below. Those of ordinaryskill in the art will recognize that any of the individual componentsdiscussed herein may be combined with other components or may be omittedaltogether without departing from the principles of the presentdisclosure.

Tool 3000 may include a handle assembly 3001. Handle assembly mayinclude an elongate structure 3002 configured to be held in the hand ofan operator or healthcare professional. As such, the elongate structure3002 may be appropriately configured and dimensioned as is known in theart. In some embodiments, elongate structure 3002 may include aplurality of geometric configurations or features 3004, such as, e.g.,bumps, grooves, indentations, ridges, knobs, cut-outs, etc. for grippingby an operator. In addition, elongate structure 3002 may include aconstant cross-sectional dimension throughout its length, or elongatestructure 3002 may include varying dimensions throughout its length.Further, elongate structure 3002 may include a substantially circularcross-sectional configuration. In some embodiments, however, elongatestructure 3002 may include any suitable cross-sectional configuration,including, but not limited to, square, rectangular, triangular, etc.

A generally cylindrical extension member 3006 may extend away from asuperior surface 3005. For the purposes of FIGS. 30-31 only, theorientation depicted is presumed to be an orientation during operation.Thus, terms such as “superior,” “anterior,” “proximal,” “distal,”“inferior,” and “posterior” are used relative to this orientation. Theextension member 3006 may serve to rotatably connect elongate structure3002 to holder 3008.

Holder 3008 may include any suitable configuration known in the art. Inone embodiment, holder 3008 may be configured, shaped, and sized toreceive and frictionally engage a proximal portion of an inserter forkdescribed in greater detail below. In one embodiment, for example,holder 3008 may include a substantially U-shaped configuration. Theinserter fork may be received with the “U” portion 3008 a of the holder3008. The U-shaped holder 3008 may include a base portion, and twosuperiorly extending arms 3009. One or more of arms 3009 may be providedwith one or more geometric features for frictionally engaging andretaining the inserter fork. For example, the geometric features mayinclude dents, indents, recesses, apertures, protrusions, ribs, and thelike. In one embodiment, an inner surface of an upper portion of eacharm 3009 may include a rib 3010. In some embodiments, the U-shapedholder 3008 may include a securing member for retaining (by, e.g.,friction) the inserter fork within holder 3008. In one embodiment, thesecuring member may be selectively actuatable. For example, the baseportion of the holder 3008 may include a set screw (not shown) or othersimilar mechanism that may selectively engage a portion of the inserterfork to retain the inserter fork relative to the holder 3008. The setscrew may be configured to transition between a first configuration anda second configuration. In the first configuration, the set screw may bereceived substantially completely or completely within the base portionof holder 3008. In the second configuration, the set screw may beadvanced out of the base portion 3008 and into the “U” portion 3008 a.The set screw may be configured to transition between the first andsecond configurations by rotating elongate structure 3002 relative toholder 3008 in the directions shown by arrow A. For example, rotatingelongate structure 3002 may rotate a head (not shown) of the set screw,thereby advancing the set screw out of the base portion of holder 3008.

With continued reference to FIG. 31, the inserter fork may include agenerally elongate structure 3012. In some embodiments, the elongatestructure 3012 may define one or more lumens therein. For example, asshown in FIG. 32A, the elongate structure 3012 may define a lumen 3014therethrough. Elongate structure 3012 may include any suitablecross-sectional structure known in the art. For example, in someembodiments, the elongate structure 3012 may be a generally tubularstructure. In other embodiments, elongate structure 3012 may include asubstantially rectangular cross-sectional configuration. In a furtherembodiment, the cross-sectional configuration of elongate structure 3012may vary along its length. For example, as shown in FIG. 31, a distalportion of elongate structure 3012 may include a substantially square orrectangular cross-sectional configuration and a proximal portion ofelongate structure 3012 may include a substantially circularcross-sectional configuration.

With reference to FIGS. 31 and 33, a distal portion of elongatestructure 3012 may be configured in a fork-like configuration. Moreparticularly, a distal portion of elongate structure 3012 may include avertical slit 3016 defining two arms 3018 and 3020. Although only twoarms 3018, 3020 are shown, those of ordinary skill in the art willunderstand that a greater or lesser number of arms may be contemplate inaccordance with the principles of the present disclosure. For example,the distal portion of elongate structure 3012 may include only a singlearm. Alternatively, elongate structure 3012 may include two longitudinalslits disposed in perpendicular planes, thereby creating four arms (notshown). As a result of one or more of the configuration of the elongatestructure 3012, the configuration of slit 3016, and the materialproperties of elongate structure 3012, the arms 3018 and 3020 mayexhibit resiliency or other spring-like characteristics. For examples,the arms 3018 and 3020 may be biased away from one another. In anotherembodiment, the arms 3018 and 3020 may be biased toward one another.

The arms 3018 and 3020 may be substantially similar to one another.Accordingly, for the purposes of efficiency, only the features of arm3020 will be described. Those of ordinary skill will understand that arm3018 may include one or more features of arm 3020. With specificreference to FIG. 33, a distal end 3022 of arm 3020 may be configured toreleasably engage proximal portion 2702 of spacer 2700 via features2706. More particularly, the distal end 3022 of arm 3020 may include aprojection 3024 configured and shaped to be received within feature2706. For example, as shown in FIG. 33, projections 3024 may beconfigured to extend towards each other. In some embodiments, feature2706 may include a projection, and the distal end 3022 of arm 3020 mayinclude a notch or other recess for releasably engaging the projection.Furthermore, a distal end portion of arm 3020 proximate to projections3024 may include one or more geometric features configured for assistingin urging arm 3020 towards arm 3018 and vice versa. More particularly,an external surface of arm 3020 may include a rib 3026, which may beengaged by sleeve 3030 to urge arm 3020 toward arm 3018. The rib 3026may include any suitable configuration known in the art. For example, inone embodiment, the rib may extend generally transverse to alongitudinal axis of the elongate structure 3012. In some embodiments, aproximal portion of rib 3026 may be configured to transition smoothly toan external surface of the remainder of arm 3020. That is, a proximalportion of rib 3026 may include a tapering or a generally ramp-likeconfiguration. Further, although only one rib 3026 is depicted on arm3020, those of ordinary skill will understand that any suitable numberof ribs 3026 may be provided. Furthermore, the rib 3026 may include aheight dimension that correlates to an amount of travel needed to movearm 3020 toward arm 3018 (and vice versa) so as to effectively engagespacer 2700.

With renewed reference to FIGS. 31 and 32A-B, a proximal end portion3013 of elongate structure 3012 may be configured as follows. In oneembodiment, the proximal end portion 3013 may include a horizontal slit3028, which may extend from the proximal end of elongate structure 3012distally to a position just proximal of knob 3032 on elongate structure3012. The slit 3028 may define two arms 3028 a, 3028 b, which may beconfigured to be either biased away or toward one another. A proximalend of each arm 3028 a, 3028 b may be configured to assist securing theinserter fork to an actuator assembly, which will be discussed ingreater detail below. In an embodiment, the proximal end of at least oneof arms 3028 a, 3028 b may include a raised flange 3027.

As alluded to above, elongate structure 3012 may include a knob 3032disposed thereon. Knob 3032 may include any suitable configuration. Inone embodiment, knob 3032 may be disposed distally of slit 3028. Anouter surface of knob 3032 may include suitable geometric features forsecuring knob 3032 within holder 3008. For example, an outer surface ofknob 3032 may include a plurality of knurls, indents, recesses, and/orprojections thereon. In one embodiment, knob 3032 may include aplurality of channels 3031 disposed thereon. The channels 3031 may beconfigured to receive at least one of ribs 3010 to facilitate securingknob 3032 with holder 3008. In some embodiments, elongate structure 3012may include a mechanism for limiting longitudinal movement of elongatestructure 3012 relative to holder 3008. For example, elongate structure3012 may include a radially extending flange 3033 configured to abut oneof arms 3009 or the base portion of U-shaped holder 3008 so as toprevent elongate structure 3012 from moving proximally relative tohandle 3001. Furthermore, elongate structure 3012 may include aplurality of screw threads 3029 disposed on an external surface thereof.In one embodiment, the threads 3029 may be disposed proximally of slit3016 but distally of flange 3033. As shown in FIG. 31, threads 3029 maybe disposed substantially closer to flange 3033 than slit 3016.

Elongate structure 3012 may be configured to be received within a lumen3030 a of sleeve 3030. Sleeve 3030 may include any suitableconfiguration known in the art. For example, sleeve 3030 generally mayinclude a configuration corresponding to an outer periphery of elongatestructure 3012. More particularly, sleeve 3030 may include a distalportion having a substantially rectangular cross-sectionalconfiguration, and a proximal portion having a substantially circularcross-sectional configuration. The lumen 3030 a within sleeve 3030 maybe similarly configured. That is, lumen 3030 a may include aconfiguration that corresponds to an outer periphery of elongatestructure 3012. That is, lumen 3030 a may include a distal portionhaving a substantially rectangular cross-sectional configuration, and aproximal portion having a substantially circular cross-sectionalconfiguration. A proximal portion of lumen 3030 a may include a widthdimension larger than a similar width dimension at a distal portion oflumen 3030 a. In addition, a distal end of lumen 3030 a may beconfigured to urge arms 3018 and 3020 towards one another so that theymay engage spacer 2700, as discussed herein. Further, in one embodiment,sleeve 3030 may be a substantially elongate hollow member having a neckportion 3034 and a proximal lip 3036 at a proximal end thereof. Insteadof lip 3036, those of ordinary skill in the art will understand that anysuitable geometric configuration may be used within the principles ofthe present disclosure.

Prior to being received over elongate structure 3012, a proximal portionof sleeve 3030 may be operably coupled to an inserter knob 3038.Inserter knob 3038 may be any suitable knob known in the art and mayinclude any suitable configuration. In one embodiment, knob 3038 mayinclude a generally cylindrical configuration. However, any suitableconfiguration may be used in accordance with the principles of thepresent disclosure. Knob 3038 may include at least one lumen 3040. Lumen3040 may extend completely through knob 3038 or partially therethrough.A distal portion of an inner surface of lumen 3040 may include at leastone geometric feature 3042 for interacting with lip 3036 so as to retaininserter knob 3038 on sleeve 3030. In one embodiment, geometric feature3042 may include a circumferential channel configured to receive lip3036 therein. With reference now to FIG. 32A, lumen 3040 may include aplurality of screw threads 3044 for cooperating with threads 3029 onelongate structure 3012. Although the depicted embodiment illustratesthat screw threads 3044 are disposed at a proximal portion of lumen3040, threads 3044 may be disposed along any portion of lumen 3040. Forexample, in one embodiment, threads 3044 may extend from a midpoint oflumen 3040 to a proximal end thereof.

With reference now to FIGS. 31-32C, actuator assembly 3050 will bedescribed. Actuator assembly 3050 may include a plurality of componentsoperably coupled together and operable to facilitate expanding spacer2700, as discussed below in greater detail. Although the plurality ofcomponents are described individually, those of ordinary skill in theart will appreciate that any of the described components may be combinedwith one or more of the other components and/or eliminated altogetherwithout departing from the principles of the present disclosure.

Actuator assembly 3050 may include a central portion 3052, which mayinclude a proximal head 3054 and an elongate tubular member 3056extending therefrom. Central portion 3052 may define a lumen 3058. Lumen3058 may extend completely through central portion 3052. Lumen 3058 mayinclude any suitable configuration known in the art. For example, asshown, lumen 3058 may include a substantially circular cross-sectionalconfiguration. In one embodiment, proximal end 3054 may include achannel 3060 for receiving a locking tab 3062 therein, which will bediscussed in greater detail below. Channel 3060 may include any suitableconfiguration, and may be dimensioned and shaped to correspond tolocking tab 3062. Further, channel 3060 may be configured to cut throughlumen 3058, as shown in FIG. 32B. In addition, a portion of lumen 3058may include a plurality of screw threads 3064. The screw threads 3064may be disposed along any portion of lumen 3058. For example, in thedepicted embodiment, screw threads 3064 may be disposed along only aproximal portion of lumen 3058. Screw threads 3064 may be disposed inlumen 3058 on either side of channel 3060. The screw threads 3064 mayextend until a proximalmost end of lumen 3058.

Externally, proximal head 3054 may include any suitable configuration.In the depicted embodiment, for example, proximal head 3054 may includea substantially planar proximal end face 3066. The end face 3066 mayinclude an opening 3067 in communication with lumen 3058. In addition,end face 3066 may include a second opening 3068 for receiving aretention pin 3069 therein. Opening 3068 include a diameter that issmaller than opening 3067. As will be discussed below, retention pin3067 may be disposed in opening 3068 for retaining tab 3062 in channel3060. Proximal head 3054 may include a generally circularcross-sectional configuration. In one embodiment, however, proximal head3054 may include substantially planar superior 3070 and inferior (notshown) surfaces. As depicted in FIG. 32C, planar superior surface 3070may include an opening 3071 in communication with channel 3060 forreceiving tab 3062 therein. With continued reference to FIGS. 32B-32C,central portion 3052 may include any suitable external configurationknown in the art. In one embodiment, central portion 3052 may include asubstantially uniform external configuration. In the depictedembodiment, central portion 3052 may include a step 3072. Step 3072 maybe located at any portion along a length of central portion 3052. In oneembodiment, step 3072 may be located at a midpoint of central portion3052. Step 3052 may include any suitable configuration. For example,step 3052 may be the interface between a relatively smaller diameterdistal portion 3052 a of central portion 3052 and a relatively largerdiameter proximal portion 3052 b of central portion 3052. As shown in,e.g., FIG. 32C, step 3072 may include a ramped surface in someembodiments. Further, a portion of proximal portion 3052 b may beconfigured to receive sleeve member 3076 thereon. Accordingly, proximalportion 3052 b may include one or more suitable geometricconfigurations, such as, e.g., screw threads 3074, for coopering withcorresponding screw threads 3077 within sleeve member 3076, as describedin greater detail below. Screw threads 3074 may extend along any portionof proximal portion 3052 b. For example, screw threads 3074 may extendalong a substantial entirety of proximal portion 3052 b or only for aportion thereof.

Distal portion 3052 may be configured, sized, and dimensioned to bereceived within a lumen defined by arms 3028 a and 3028 b. In oneembodiment, distal portion 3052 may include a diameter (or if nottubular, a width dimension) that is larger than a diameter (or widthdimension) of the lumen defined by arms 3028 a, 3028 b, so as to spreadapart arms 3028 a, 3028 b when distal portion 3052 is receivedtherebetween. In this manner, distal portion 3052 may be frictionallyretained by the inherent resilient properties of arms 3028 a, 3028 bacting on distal portion 3052. To facilitate with orientation andguiding distal portion 3052 into the lumen defined by arms 3028 a, 3028b, distal portion 3052 may include one or more projections 3075, whichmay be configured to be slidably received within slit 3028.

As noted above, opening 3071 and channel 3060 may be configured toreceive therein a locking tab 3062 for receiving a tool within lumen3058 of actuator 3050. Tab 3062 may include any suitable configurationknown in the art. In one embodiment, tab 3062 may be resiliently biasedin a direction out of channel 3060 by one or more springs or spring likemembers 3063. Further, tab 3062 may be retained in channel 3060 byretention pin 3069, described above. Tab 3062 may further define apassageway 3062 a therethrough. Passageway 3062 a may include anyconfiguration known in the art. As discussed below, passageway 3062 amay be configured (e.g., may include one more projections) to engagechannel 3206 of threaded shaft 3200 for retaining threaded shaft withinactuator assembly 3050.

Sleeve 3076 may include a generally cylindrical member defining a lumen3078 therethrough. Sleeve 3076 may include any suitable configurationknown in the art. In one embodiment, sleeve 3076 may include a generallycircular cross-sectional configuration. However, sleeve 3076 may includeany suitable cross-sectional configuration. Further, a distal end ofsleeve 3076 may include a generally tapered configuration. Lumen 3078may include a generally circular cross-sectional configuration, and maybe configured to receive proximal portion 3052 b therein. Indeed, asalluded to above, lumen 3078 may include a plurality of threads 3077configured to mate with threads 3074 to retain sleeve 3076 on centralportion 3052. Threads 3077 may extend along any suitable portion oflumen 3078. In one embodiment, for example, threads may extend anentirety of lumen 3078. In another embodiment, threads 3077 may extendalong only a portion of lumen 3078.

An overall maximum diameter of sleeve 3076 may be less than a diameteror width of proximal head 3054. In addition, sleeve 3076 may include astep 3079 that defines an interface between a relatively larger diameterdistal portion 3076 b of sleeve 3076 and relatively smaller diameterproximal portion 3076 a of sleeve 3076. Step 3079 may be disposed at anysuitable location along sleeve 3076. Further, sleeve 3076 may includeone or more longitudinal grooves 3080 extending distally from a proximalend thereof. The grooves 3080 may be configured to receive rods 3081therein, which may be configured to prevent sleeve 3076 from rotatingwithin housing 3090 of actuator 3050, as described below in greaterdetail.

A washer 3082 may be configured to be frictionally retained on proximalportion 3076 a, as shown in FIG. 32B. Washer 3082 may include agenerally cylindrical structure that defines a lumen 3084 therethrough.In addition, washer 3082 may define a proximal ledge 3085 configured toabut a distal face of proximal head 3054. Washer 3082 may also include aplurality of external threads 3086 for securing housing 3090 thereon.

Housing 3090 may include a generally cylindrical structure defining alumen 3092 therethrough. Lumen 3092 may include any suitableconfiguration known in the art. For example, lumen 3092 may include agenerally circular cross-sectional configuration. However, any suitablecross-sectional configuration may used within the principles of thepresent disclosure. In embodiments where lumen 3092 includes a circularcross-sectional configuration, lumen 3092 may include a generallyconstant diameter throughout its length or a diameter that varies overthe length of lumen 3092. For example, a proximal portion of lumen 3092may include a counter bore and therefore may include a larger diameterthan a remainder of lumen 3092. A proximal portion of lumen 3092 mayalso include screw threads 3093 for threadingly engaging threads 3086 ofwasher 3082 to retain housing 3090 thereon. Threads 3093 may extendalong any suitable portion of lumen 3092. Walls of lumen 3092 mayinclude one or more grooves 3094, which may correspond to grooves 3080and be configured to receive rods 3081. Rods 3081, grooves 3904, andgrooves 3080 cooperate to prevent sleeve 3076 from rotating withinhousing 3090. Further, housing 3090 may be made of any suitablebiocompatible material known in the art, including, for example, PEEK.

Externally, housing 3090 may include any suitable configuration known inthe art. In the depicted embodiment, housing 3090 may include a raisedproximal portion 3095. Proximal portion 3095 may include any suitableconfiguration. In one embodiment, proximal portion 3095 may include ahexagonal configuration (e.g., a hexagonal cross-sectionalconfiguration) for being engaged by an appropriately configured tool.Similarly, proximal portion 3095 may include one or more geometricfeatures 3096 configured to assist with retaining a tool (discussedbelow) on proximal portion 3095. The geometric features 3096 may includea plurality of indentations, bumps, recesses, channels, etc. Housing3090 may further include a raised distal portion 3097. Raised distalportion 3097 may define a channel 3098 through housing 3090. Channel3098 may include any suitable configuration. For example, in oneembodiment, channel 3098 may extend in a direction that is substantiallyperpendicular to a longitudinal axis of lumen 3092. Channel 3098 may beconfigured to receive catch 3100 slidably therein. Further, raiseddistal portion 3097 may include one or more openings 3099 for receivingfasteners 3099 a therein. In embodiments where fasteners 3099 includethreaded fasteners such as, e.g., screws, openings 3099 may includecorresponding threads.

Catch 3100 may include any suitable configuration, and may bedimensioned and shaped to be received within channel 3098. Catch 3100may be made of any suitable material known in the art, including, e.g.,PEEK. In one embodiment, catch 3100 may include a substantiallyrectangular configuration. As shown in FIG. 31C, lateral surfaces 3102of catch 3100 may be radiused or curved so that an outer profile ofcatch 3100 may correspond to raised distal portion 3097 when catch 3100is received within channel 3098. Further, superior 3104 and/or inferiorsurfaces of catch 3100 may include one or more openings corresponding toopenings 3099. As shown in FIG. 32C, opening 3104 may include anysuitable configuration. For example, opening 3104 may include asubstantially elongate configuration, whereby fastener 3099 a may beslidably disposed in opening 3104. Consequently, catch 3100 may beconfigured to slide back and forth relative to channel 3098 withoutbecoming disengaged when fasteners 3099 are disposed in openings 3104.Moreover, catch 3100 may define a passageway 3106 therethrough forreceiving flange 3027 (at the proximal end of the inserter fork shown inFIG. 31) and/or distal portion 3052 a therethrough. Passageway 3106 mayinclude any suitable configuration known in the art. In one embodiment,a wall of passageway 3106 may define a circumferential channel 3108(shown in FIG. 32B) configured to engage flange 3027. Thecircumferential channel 3108 may be disposed completely aroundpassageway 3106 or only partially around passageway 3106.

With reference now to FIGS. 34-44 a method of operating tool 3000 andits various components to implant an exemplary embodiment of spacer 2700will be described. As shown in FIG. 34, sleeve 3030 may be advanceddistally to squeeze arms 3018, 3020 towards one another so thatprojections 3024 may engage features 2706 to secure spacer 2700 to tool3000. Sleeve 3030 may be moved distally by rotating knob 3038 relativeto elongate structure 3012. As a result of the coupling via threads 3044and 3029, rotating knob 3038 relative to elongate structure 3012 mayresult in knob 3038 and sleeve 3030 moving longitudinally relative toelongate structure 3012.

Once the spacer 2700 is secured to tool 3000, the spacer 2700 may beready for implantation within a patient. As discussed above, spacer 2700may be delivered to the interbody disc space within a patient via anysuitable procedure known in the art. For example, in one embodiment, thespacer is delivered via an anterior approach. In another embodiment, thespacer may be delivered via a posterior approach. Further, the approachangle may be any suitable angle known in the art. For example, thespacer 2700 may be delivered by tool 3000 inserted via a posteriorapproach at an angle of 20-40 degrees offset from a center line of apatient.

Once spacer 2700 is secured to the distal end of the inserter fork, athreaded shaft 3200 may be inserted into a proximal end of actuatorassembly 3050 and all the way through the distal end of sleeve 3030 intolumen 2705 of proximal portion 2702 and threaded into lumen 2744 ofdistal component 2740 of spacer 2700. With reference to FIG. 35,threaded shaft 3200 may include any suitable configuration. In oneembodiment, threaded shaft 3200 may include an elongate member 3202.Elongate member 3202 may include any suitable configuration. Inembodiment, elongate member 3202 may include a generally cylindricalconfiguration. For example, elongate member 3202 may include a generallycircular cross-sectional configuration. Further, elongate member 3202may be configured to gradually taper toward its distal end. That is, aproximal portion of elongate member 3202 may include a diameter that isrelative larger than a distal portion of elongate member 3202.

In one embodiment, a distal portion, e.g., a distal end, of elongatemember 3202 may be configured to engage distal component 2740 of spacer2700. For example, a distal portion of elongate member 3202 may includeone or more geometric configurations configured to cooperate withgeometric configurations disposed within lumen 2744 of distal component2740. In embodiments where lumen 2744 may include threads, for example,a distal portion of elongate member 3202 may also include threads 3208.

A proximal end of elongate member 3202 may include an actuating member3204. Actuating member 3204 may include any suitable configuration knownin the art. In one embodiment, actuating member 3204 may be removablycoupled to a proximal portion of elongate member 3202. In anotherembodiment, actuating member 3204 may be integrally formed with elongatemember 3202. Actuating member 3204 may include a knob or a handle insome embodiments. Accordingly, actuating member 3204 may include one ormore geometric configurations 3210 to facilitate gripping by anoperator. Geometric configurations 3210 may include ridges, channels,protrusions, projections, dents, bumps, recesses, surface texturing,etc. Further, elongate member 3202 may include a channel 3206. Channel3206 may be disposed at any suitable position along elongate member3202. In one embodiment, channel 3206 may be disposed closer to aproximal end of elongate member 3202 than a distal end. Channel 3206 maybe defined by a portion of elongate member 3202 including a relativelysmaller diameter than immediately adjacent portions of elongate member3202. Channel 3206 may be positioned at a location on elongate member3202 suitable for being engaged by passageway 3062 a (shown in FIG.32C). Further, actuating member 3204 may include one or more markings3212 (shown in FIG. 38A) for indicating a degree of expansion of spacer2700, as described further below. The markings 3212 may include anysuitable markings known in the art and may include numerical valuescorresponding to a percentage of expansion of spacer 2700.

Turning now to FIG. 36, tool 3000 may be secured to spacer 2700 andthreaded shaft 3200 may be received within tool 3000. Tool 3000 may bethen inserted into a patient to effect implantation of spacer 2700within the patient. In some embodiments, however, tool 3000 and spacer2700 may be already positioned within a patient when threaded shaft 3200is inserted into tool 3000 and secured to spacer 2700.

Turning now to FIG. 37, an expanding hex cap 3700 may be positioned overa proximal end of tool 3000 and actuating member 3204. In oneembodiment, hex cap 3700 may include a generally cylindrical memberdefining a lumen 3702 therein. Lumen 3702 may extend completely throughhex cap 3700 or may be blind, such that hex cap 3700 includes a closedproximal end. A distal end portion 3704 of hex cap 3700 may beconfigured to be received over and engage proximal portion 3095.Accordingly, distal end portion 3704 may include a configuration thatcorresponds to proximal portion 3095. For example, distal end portion3704 may be shaped as a hexagonal tool. Further, an inner surface oflumen 3702 in distal portion 3704 may include one or more geometricfeatures 3706 configured to engage geometric features 3096 on proximalportion 3095. In one embodiment, geometric features 3706 may include aplurality of bumps while geometric features 3096 may include a pluralityof recesses, or vice versa. In addition, as depicted in FIG. 37, distalend portion 3704 may include a diameter relatively larger than aproximal portion 3708 of hex cap 3700

Further, a proximal portion 3708 of hex cap 3700 may include a pluralityof windows or openings 3710 disposed radially thereabout. The openings3710 may include any suitable configuration known in the art and mayfacilitate visualizing the markings 3212 disposed on actuating member3204. Proximal portion 3708 may include any suitable number of openingsdesired.

In operation, and while spacer 2700 is appropriately positioned (e.g.,by moving hex cap 3700 in the direction of arrow 3712) within a patient,hex cap 3700 may be positioned over a proximal end of tool 3000 so thatdistal end portion 3704 may engage proximal portion 3095 of actuatorassembly and actuating member 3204 may be visible to an operator throughopenings 3710. Next, the operator may rotate hex cap 3700 to expandspacer 2700 until the desired amount of expansion if achieved. Rotatinghex cap 3700 causes proximal portion 3095 (and, consequently, housing3090) to be rotated via its engagement with distal end portion 3704. Asa result of the various components and their connections of actuatorassembly 3050 described above, when housing 3090 is rotating, sleeve3076 is also rotated because it is fixed relative to housing 3090 viarods 3081. Consequently, sleeve 3076 and housing 3090 are translatedlongitudinally relative to central portion 3052. Further, because aproximal end flange 3027 is secured to housing 3090 via catch 3100, theentire inserter fork also translates longitudinally relative to centralportion 3052 when hex cap 3700 is rotated. And, since threaded shaft3200 is secured to central portion 3052 via catch 3206 and tab 3062, thedistal threads 3208 threaded into distal component of spacer 2700 maymove relative to proximal portion 2702 of spacer 2700 as the inserterfork is moved when hex cap 3700 is rotated. Such relative movementbetween the distal end of the inserter fork and the threaded shaft 3200causes proximal portion 2702 to move towards distal component 2740,thereby effecting expansion of spacer 2700 as the various components ofspacer are rotated from the positions depicted in FIG. 27B to thepositions depicted in FIG. 27A or any suitable, desired intermediateposition. As alluded to above, a degree of travel of, e.g., housing 3090relative to actuating member 3054 may correspond to a degree ofexpansion of spacer 2700. Accordingly, actuating member 3054 may includea plurality of markings to assist an operator in determining a degree ofexpansion of spacer 2700.

After desired expansion of spacer 2700 is achieved and spacer 2700 isappropriated positioned within the patient, hex cap 3700 may be removed.Subsequently, tab 3062 may be actuated (e.g., depressed) so that it maytemporarily be disengaged from channel 3206 and threaded shaft 3200 maybe also removed from tool 3000. In the meantime, position retainingfeatures 2721 and 2727 may interfere with one another to frictionallyretain an expanded configuration of spacer 2700. Subsequently, a lockinginstrument 3900 may be inserted into lumen 3058 and advanced throughtool 3000 until it engages within locking feature 2760.

Locking instrument 3900 (see FIG. 39) may include a generally elongatemember 3902 having a distal portion 3904 including one or more geometricconfigurations 3906 configured to engage with geometric configurations2762 a in such a manner that when locking instrument 3900 is rotated,locking feature 2760 will be rotated. As its proximal end, lockinginstrument may include a suitable actuating member, such as, e.g., ahandle or knob 3908. Handle or knob 3908 may be secured to elongatemember 3902 by any suitable means known in the art. In one embodiment,handle or knob 3908 may be removably coupled to elongate member 3902. Inother embodiments, handle or knob 3908 may be integrally formed withelongate member 3902. In some embodiments, locking instrument 3900 maybe a torque limiting tool. That is, locking instrument 3900 may beconfigured to prevent application of torque above a predetermined limit.For example, once a predetermined limit of applied torque is exceeded,handle or knob 3908 may rotate freely relative to elongate member 3902.Handle or knob 3908 may include any suitable configuration known in theart to facilitate gripping and operation by a user. In one embodiment,handle or knob 3908 may include one or more geometric features 3909(e.g., detents, recesses, protrusions, etc.) configured to allowmanipulation by a user.

In operation, distal portion 3904 may be inserted into lumen 2762 so asto engage geometric configurations 2762 a, as shown in FIG. 40. Next,handle or knob 3908 may be rotated to advance locking feature 2760 intospace 2708 to prevent links 2710 from returning to their collapsedposition, thereby locking spacer 2700 in the expanded configuration.

Next, locking instrument 3900 may be removed from tool 3000 and a funneltube 4100 (see FIG. 41) having a funnel 4200 removably coupled theretomay be inserted into tool 3000 via lumen 3058. Funnel tube 4100 mayinclude any suitable configuration known in the art. In one embodiment,funnel tube 4100 may include an elongate member 4102 defining a lumen4104 therethrough. Elongate member 4102 may include any suitableconfiguration. For example, elongate member 4102 may include a generallycircular cross-sectional configuration. In some embodiments, however,other cross-sectional configurations, such as, e.g., rectangular, may beused. Similarly, lumen 4104 may include a substantially circularcross-sectional configuration, but any suitable configuration may beemployed within the principles of the present disclosure. Elongatemember 4102 may have a length sufficient to extend from outside aproximalmost end of tool 3000 to beyond a distal end of locking feature2760, so as to deliver material into a center of spacer 2700 when it isin the expanded configuration, as discussed below in greater detail.

A proximal end portion 4106 of elongate member 4102 may be configured tobe removably secured within lumen 3058. More particularly, proximal endportion 4106 may include threads 4108 configured to engage threads 3064in proximal head 3054 so as to retain funnel tube 4100 therein. Funneltube 4100 may further include a knob 4110 disposed proximally of threads4108. In some embodiments, knob 4110 may include a diameter that isrelatively larger than a diameter of a remainder of funnel tube 4100. Inaddition, knob 4110 may define a lumen (not shown) therethrough. In someembodiments, the lumen of knob 4110 may include a diameter that isrelatively larger than a diameter of the lumen 4104 through a remainderof funnel tube 4100. Knob 4110 may also include a plurality of geometricconfigurations 4112 located on an external surface thereof. Thegeometric configurations 4112 may include any suitable configurationknown in the art. In one embodiment, the geometric configurations mayinclude a plurality of raised ridges, bumps, notches, recesses, detents,etc.

Funnel 4200 may be any suitable funnel known in the art. For example,funnel 4200 may include a conical portion 4202 having a tapering cavitytherein. The conical portion 4202 may be secured to or integrally formedwith a neck portion 4204 having a lumen defined therethrough. The lumenin neck portion 4204 may be in communication with conical portion 4202.Neck portion 4204 may be removably secured to proximal end portion 4106by any suitable means known in the art. In one example, neck portion4204 may include threads configured to matingly engage correspondingthreads 4113 (shown in FIG. 43) disposed on proximal end portion 4106.In one embodiment, a portion of proximal end portion may be receivedwithin neck portion 4204. In another embodiment, a portion of neckportion 4204 may be received within proximal end portion 4106.

In use, funnel tube 4100 may be advanced into lumen 3058 and securedtherein by engaging threads 4108 with threads 3064, such that a distalopening of lumen 4104 is disposed through locking feature 2760 withinspacer 2700, as shown in FIG. 42. Next, the space within spacer 2700 maybe filled with morcellated bone (e.g., autograft) or any other suitablematerial into the center of spacer 2700 when it is in the expandedposition. Subsequently, funnel 4200 may be decoupled from funnel tube4100 by, e.g., unscrewing it. Next, a bone funnel pusher 4300 may beinserted through funnel tube 4100 to push or advance any morcellatedbone graft or other material remaining in funnel tube 4100 out of funneltube 4100 and into a center of spacer 2700.

As shown in FIG. 43, bone funnel pusher 4300 may include a generallyelongate member 4302 having a proximal end 4304 and a distal end 4306.Pusher 4300 may include any suitable configuration known in the art.Elongate member 4302 may include any suitable configuration known in theart. For example, elongate member 4302 may include a generally circularcross-sectional configuration. However, elongate member 4302 may includeany suitable configuration known in the art. In one embodiment, pusher4300 may be sized to be advanced through tool 3000 to spacer 2700. Atits proximal end 4304, pusher 4300 may include a handle 4305. Handle4305 may include any suitable configuration. For example, handle 4305may include a generally tubular structure. Handle 4305 may include adiameter that is relatively larger than a diameter of elongate member4302. At its distal end 4306, elongate member may include a pushingmember 4307. Pushing member 4307 may include any suitable configuration.For example, pushing member 4307 may be substantially tubular. In oneembodiment, pushing member 4307 may include a diameter that isrelatively larger than a diameter of elongate member 4302, butrelatively smaller than a diameter of handle 4305.

In use, the bone funnel pusher 4300 may be used to fill spacer 2700with, e.g., finely milled autogenous bone graft material to tightly packspacer 2700. Once the graft material is tightly packed within spacer2700, the inserter knob 3038 may be rotated to withdraw sleeve 3030 todisengage the inserter fork from spacer 2700. Prior to finaldisengagement, however, a user may choose to verify a final positioningof the spacer 2700 via radiographic visualization, such as, e.g.,fluoroscopy, X-ray, or any other suitable imaging technique, as shown inFIG. 44.

If necessary, the spacer 2700 may be removed or otherwise manipulated byfirst inserting a removal tool (not shown) through a distal end of lumen2744 in distal component 2740. The removal tool may engage lockingfeature 2760 and advance it completely back into cylindrical portion2703 of proximal portion 2702, thereby removing the impediment to links2710 and 2712 returning to their collapsed position. Next, projections3024 of arms 3018, 3020 may engage features 2706 as described above.Threaded shaft 3200 may then be inserted through tool 3000 to engagethreads 3208 within distal component 2740. Subsequently, hex cap 3700may be provided over a proximal end of tool 3000 for rotation so as tocollapse 2700 for removal from within the patient.

As described above, the devices, tools, and methods described herein maybe used to provide an interbody spacer for positioning between adjacentvertebral bodies. Prior to performing the above-described steps, thoseof ordinary skill in the art will understand that a patient's nativeintervertebral disc may be first removed via a conventional discectomy,for example. Alternatively, scrapers may be used for disc distractionsand to loosen the disc space without damaging vertebral endplates. Inone embodiment, an operator may begin distraction with a relativelysmall scraper and proceed with increasingly larger scrapers. Next, thedisc space may be prepared for receiving, for example, spacer 2700 asknown in the art. Subsequently, measurements may be made of a height andwidth of the interbody disc space to ensure a spacer of correctdimensions is selected for implantation. The measurements may be made byany suitable means known in the art. For example, a user may conduct oneor more adjustable footprint trials. In particular, one or more trialsmay be inserted into the prepared disc space in a collapsedconfiguration and expanded. The trial may be observed under suitableimaging means, such as, e.g., fluoroscopy, to identify appropriatesizing suitable for the prepared disc space.

While the invention herein disclosed has been described by means ofspecific embodiments and applications thereof, numerous modificationsand variations can be made thereto by those skilled in the art withoutdeparting from the scope of the invention as set forth in the claims.

What is claimed is:
 1. A system for treating a vertebral condition, thesystem comprising: an interbody implant configured to transition betweena first configuration and a second configuration, wherein the interbodyimplant comprises: a first arm including a first end and a second end,wherein the first arm is defined by a plurality of links coupled to oneanother; a second arm including a first end and a second end, whereinthe second arm is defined by a plurality of links coupled to oneanother; a proximal component coupled to the first ends of the first andsecond arms, wherein the proximal component includes a lumen withthreads; a distal component coupled to the second ends of the first andsecond arms; and a locking feature received in the lumen, wherein thelocking feature includes threads that engage the threads of the lumen;and an instrument for positioning the implant within a patient, theinstrument comprising: a handle assembly comprising a holder element; anelongate member received in the holder element, wherein the elongatemember includes a fork-like end for grasping the interbody implant; asleeve positioned over the elongate member; an actuator assemblyoperably attached to a proximal portion of the elongate member; and athreaded shaft insertable into a proximal portion of the actuatorassembly and through the sleeve, wherein in the handle assembly has alongitudinal axis that is transverse to a longitudinal axis of theelongate member.
 2. The system of claim 1, wherein the firstconfiguration is a collapsed configuration and the second configurationis an expanded configuration.
 3. The system of claim 1, wherein one orboth of the proximal and distal components includes a passagewaytherethrough.
 4. The system of claim 1, wherein the plurality of linksdefining the first arm are configured to engage each other to maintain aposition of a first link of the plurality of links relative to anotherlink of the plurality of links.
 5. The system of claim 1, furthercomprising a locking mechanism for preventing the implant from returningto the second configuration from the first configuration when thelocking mechanism is activated.
 6. The system of claim 1, wherein adistal end of the elongate member includes a plurality of resilientarms.
 7. The system of claim 6, wherein the sleeve is configured to urgeat least one of the plurality of resilient arms towards the other of theplurality of resilient arms.
 8. The system of claim 1, wherein aproximal end of the elongate member comprises one or more horizontalslits.
 9. The system of claim 8, wherein the actuator assembly comprisesone or more projections that are received in the one or more horizontalslits.
 10. A method of positioning an interbody implant in a spacebetween adjacent vertebral bodies, the method comprising: positioningthe interbody implant within the space using an instrument, wherein theinterbody implant comprises: a first arm including a first end and asecond end, wherein the first arm is defined by a plurality of linksrotatably coupled to one another; a second arm including a first end anda second end, wherein the second arm is defined by a plurality of linksrotatably coupled to one another; a proximal component coupled to thefirst ends of the first and second arms, wherein the proximal componentincludes a lumen with threads; and a distal component coupled to thesecond ends of the first and second arms; transitioning the interbodyimplant from a first configuration to a second configuration; andactivating a locking mechanism to maintain the interbody implant in thesecond configuration, wherein the instrument comprises: a handleassembly comprising a holder element; an elongate member received in theholder element, wherein the elongate member includes a fork-like end forgrasping the interbody implant; a sleeve positioned over the elongatemember; an actuator assembly operably attached to a proximal portion ofthe elongate member; and a threaded shaft insertable into a proximalportion of the actuator assembly and through the sleeve, wherein in thehandle assembly has a longitudinal axis that is transverse to alongitudinal axis of the elongate member.
 11. The method of claim 10,further comprising removing a native disc and preparing the space priorto inserting the expandable interbody implant.
 12. The method of claim10, further comprising measuring at least one of a height and a widthdimension of the space.
 13. The method of claim 10, wherein positioningthe interbody implant within the space includes advancing the interbodyimplant to the space via a lateral approach.
 14. The method of claim 10,wherein, in the second configuration, the interbody implant encloses aregion defined by the first arm, the second arm, the proximal component,and the distal component.
 15. The method of claim 10, further comprisingdelivering a material to the region.
 16. The method of claim 10, whereinthe plurality of links defining the first arm are configured to engageeach other to maintain a position of a first link of the plurality oflinks relative to another link of the plurality of links.
 17. The methodof claim 10, further comprising visualizing the implant via fluoroscopy.18. The method of claim 10, wherein the actuator assembly comprises oneor more projections that are received in one or more horizontal slits ofthe elongate member.